Quality Assurance Manager
上海勃林格殷格翰药业有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2014-05-30
- 工作地点:泰州
- 招聘人数:1
- 工作经验:十年以上
- 学历要求:硕士
- 语言要求:英语精通
- 职位月薪:20000-29999
- 职位类别:生物工程/生物制药
职位描述
Position Title: Quality Assurance Manager
Basic Purpose of the Position
Responsible for management, budgeting and day to day operations of Quality Assurance pertaining to release of components, raw materials, products, internal and external vendor audits, GXP training, and administration of key QA systems such as CAPA, deviations, complaint management, validation reviews, change control, controlled documents such as SOPs, Batch records etc . Responsible for implementing procedures to assure compliance with FDA, EU, USDA, and corporate requirements. Responsible for all quality improvement initiatives arising out of audit and inspectional findings.
Accountabilities
?Manages the overall operation of the department. Prioritizes work, resolves issues, develops and institutes quality and efficiency improvements, and conducts performance reviews.
?Interprets requirements for compliance and creates, develops, and implements Departmental procedures and policies. Initiates review and revision of testing procedures and specifications. Ensures that policies, SOPs, and safety procedures are instituted and followed.
?Manages expenditures relating to laboratory operations and instrumentation.
?Maintains personal knowledge skills in the awareness of current regulatory and corporate practices.
?Responsible for sourcing, introducing, and bringing new instrumentation/technology into the department.
?Responsible for providing technical guidance, training and oversight for the department and its members.
?Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management.
?Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI’s excellent reputation in the community.
Requirements
?Masters Degree or advanced degree in scientific discipline
?Scientific and analytical thinking
?Excellent reading/writing and communication skills
?Well versed in statistical analysis
?Computerized quality systems and other relevant applications
?Ability to lead cross function teams for quality initiatives
?Well versed in FDA/USDA and EU regulations
?Good command in English
Required Skills
?Well versed in all regulatory requirements, inclusive of cGMP/GLP and BI requirements
?Ability to effectively manage a substantial number of people.
?Effective interpersonal skills with a diverse group of individuals at all organizational levels
?Proficiency in relevant computer software and programs associated with area.
?Excellent written and verbal communication skills.
?Attention to detail and commitment to customer service.
?Ability to evaluate and interpret data and formulate logical and sound conclusions and recommendations.
?Ability to use technical knowledge to solve problems.
Basic Purpose of the Position
Responsible for management, budgeting and day to day operations of Quality Assurance pertaining to release of components, raw materials, products, internal and external vendor audits, GXP training, and administration of key QA systems such as CAPA, deviations, complaint management, validation reviews, change control, controlled documents such as SOPs, Batch records etc . Responsible for implementing procedures to assure compliance with FDA, EU, USDA, and corporate requirements. Responsible for all quality improvement initiatives arising out of audit and inspectional findings.
Accountabilities
?Manages the overall operation of the department. Prioritizes work, resolves issues, develops and institutes quality and efficiency improvements, and conducts performance reviews.
?Interprets requirements for compliance and creates, develops, and implements Departmental procedures and policies. Initiates review and revision of testing procedures and specifications. Ensures that policies, SOPs, and safety procedures are instituted and followed.
?Manages expenditures relating to laboratory operations and instrumentation.
?Maintains personal knowledge skills in the awareness of current regulatory and corporate practices.
?Responsible for sourcing, introducing, and bringing new instrumentation/technology into the department.
?Responsible for providing technical guidance, training and oversight for the department and its members.
?Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management.
?Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI’s excellent reputation in the community.
Requirements
?Masters Degree or advanced degree in scientific discipline
?Scientific and analytical thinking
?Excellent reading/writing and communication skills
?Well versed in statistical analysis
?Computerized quality systems and other relevant applications
?Ability to lead cross function teams for quality initiatives
?Well versed in FDA/USDA and EU regulations
?Good command in English
Required Skills
?Well versed in all regulatory requirements, inclusive of cGMP/GLP and BI requirements
?Ability to effectively manage a substantial number of people.
?Effective interpersonal skills with a diverse group of individuals at all organizational levels
?Proficiency in relevant computer software and programs associated with area.
?Excellent written and verbal communication skills.
?Attention to detail and commitment to customer service.
?Ability to evaluate and interpret data and formulate logical and sound conclusions and recommendations.
?Ability to use technical knowledge to solve problems.
公司介绍
关于勃林格殷格翰
加入勃林格殷格翰,与我们一起携手并肩,共创未来。我们深信每一位员工的成长都将铸就公司的发展,每一位员工的努力也都将成就公司的美好明天。130余年来,研发驱动型制药公司勃林格殷格翰作为全球前20大制药企业之一,持续致力于人用药品、动物保健和生物制药合同生产三大业务领域,力争为人类和动物带来更多健康。加入勃林格殷格翰,将是您实现“创新展现价值”的绝佳机会!在工作中,您将通过与内外部伙伴的通力合作,站在知识迭代的最前沿;科研过程中,您将不断探索新型科学发现,切实提高全人类的生活质量;与此同时,您也将助力公司成为未来行业当之无愧的领导者。
我们的业务正处在持续高速发展之中,是中国业内发展最快的公司之一。我们诚邀您加入勃林格殷格翰,共同携手向前,成为实现2025愿景的一份子。
作为业内的领导企业,热情、创新和独立是驱动我们不懈前行的动力,我们为每一位努力热忱、恪尽职守的员工提供成长机会,实现其个人价值。作为连续七年通过“中国杰出雇主”认证的企业,我们通过提供高质量的职业发展规划、参与或领导国际项目的机会,为每一位员工的成功之路夯实基础。
让我们彼此成就,引领未来!
想获取更多信息,有以下方式:
1. 访问************************************/或
2. 关注我们领英账号, 或
3. 关注我们的微信公众号:BI招聘
行为准则
-责任心:即使情况不明朗,我们总是在自己的决策和行为中展现主人翁精神
-敏锐度:面对内外部变化时,我们以开放的心态快速应对
-内部企业家精神:我们与客户携手构筑创新理念,以应对瞬息万变的市场
联系我们
如果你坚信自己就是我们要找的人,不要犹豫,马上申请吧!
加入勃林格殷格翰,与我们一起携手并肩,共创未来。我们深信每一位员工的成长都将铸就公司的发展,每一位员工的努力也都将成就公司的美好明天。130余年来,研发驱动型制药公司勃林格殷格翰作为全球前20大制药企业之一,持续致力于人用药品、动物保健和生物制药合同生产三大业务领域,力争为人类和动物带来更多健康。加入勃林格殷格翰,将是您实现“创新展现价值”的绝佳机会!在工作中,您将通过与内外部伙伴的通力合作,站在知识迭代的最前沿;科研过程中,您将不断探索新型科学发现,切实提高全人类的生活质量;与此同时,您也将助力公司成为未来行业当之无愧的领导者。
我们的业务正处在持续高速发展之中,是中国业内发展最快的公司之一。我们诚邀您加入勃林格殷格翰,共同携手向前,成为实现2025愿景的一份子。
作为业内的领导企业,热情、创新和独立是驱动我们不懈前行的动力,我们为每一位努力热忱、恪尽职守的员工提供成长机会,实现其个人价值。作为连续七年通过“中国杰出雇主”认证的企业,我们通过提供高质量的职业发展规划、参与或领导国际项目的机会,为每一位员工的成功之路夯实基础。
让我们彼此成就,引领未来!
想获取更多信息,有以下方式:
1. 访问************************************/或
2. 关注我们领英账号, 或
3. 关注我们的微信公众号:BI招聘
行为准则
-责任心:即使情况不明朗,我们总是在自己的决策和行为中展现主人翁精神
-敏锐度:面对内外部变化时,我们以开放的心态快速应对
-内部企业家精神:我们与客户携手构筑创新理念,以应对瞬息万变的市场
联系我们
如果你坚信自己就是我们要找的人,不要犹豫,马上申请吧!
联系方式
- Email:HRTACampusWest.CN@boehringer-ingelheim.com
- 公司地址:地址:span张江李时珍路257号